Can Protein Intake be Increased Using Whole Foods Post-treatment in Cancer Patients?

NCT05859100 | Completed

• 1 other identifier: HREBA.CC-22-0348
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Cancer and its treatments often result in severe toxicities and side effects that, over the course of treatment, results in weight loss and depletion of key nutrients. Loss of muscle mass and strength during cancer treatment is a critical problem because it negatively affects patient response and tolerance to therapy and post-treatment recovery. To restore the nutritional status, it is imperative to stimulate muscle protein anabolism. Eggs are high quality protein source, popular and well tolerated by cancer patients. Therefore, the objective of this study is to determine whether a nutritional intervention of ≥2 eggs can aid in restoring nutritional status and improving immune function and quality of life of cancer patients' post-treatment. It is an 8- week randomised clinical trial with parallel arm assignment. Half of the participants will receive the nutritional intervention (Early Intervention) and the other half will be on standard of care or usual diet for first 4 weeks. Starting from week 5, all participants will receive the nutrition intervention till week 8 (Delayed Intervention). Dietary intake (foods and nutrients), cumulative protein intake (g protein/kg body weight), immunological measures, physical performance and quality of life has been planned to be assessed over time and between groups to evaluate the feasibility of an egg intervention in meeting recommended protein intakes for patients with cancer.

Conditions

Cancer; Other Malnutrition

Keywords

Cancer; Nutrition; Protein; post-chemotherapy; Recovery; food-related quality of life

Outcome Measures

Primary Outcomes (2)

• Difference in mean cumulative protein intake between the two groups at 8 weeks.

  Mean cumulative protein intake will be arrived at by normalizing protein intake in kilocalories by body weight in kilograms

  From baseline at 8 weeks

• Difference in mean cumulative protein intake within a group at 8 weeks for each group.

  Mean cumulative protein intake will be arrived at by normalizing protein intake in kilocalories by body weight in kilograms

  From baseline at 8 weeks

Secondary Outcomes (6)

• Change in Energy Intake

  From baseline at 8 weeks

• Change in Body weight

  From baseline at 8 weeks

• Change in Quality of Life

  From baseline at 8 weeks

• Change in Nutritional status and Symptom severity.

  From baseline at 8 weeks

• Change in Quality of Life related to malnutrition

  From baseline at 8 weeks

Study Arms (2)

Early Intervention

EXPERIMENTAL

Participants are expected to begin intervention immediately after the completion of treatment for a period of 8 weeks.

Other: ≥ 2 eggs in addition to usual diet for 8 weeks

Delayed Intervention

OTHER

Participants are expected to begin intervention 4 weeks after the completion of the treatment, for a period of 4 weeks (weeks 5-8).

Other: ≥ 2 eggs in addition to usual diet for 4 weeks

Interventions

≥ 2 eggs in addition to usual diet for 8 weeks OTHER

Participants are expected to consume≥ 2 eggs per day in addition to usual diet for 8 weeks in early intervention arm, beginning immediately post-treatment.

Early Intervention

≥ 2 eggs in addition to usual diet for 4 weeks OTHER

Participants are expected to continue intake of regular diet beginning immediately at post-treatment recovery for a duration of 4 weeks, then crossover to nutritional intervention arm from weeks 5 to 8 of post-treatment recovery for a duration of 4 weeks.

Delayed Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up.
• ≥18 years of age
• Histopathologically confirmed cancer with receipt of a platinum chemotherapy during treatment; active treatment has concluded.
• Capable of volitional oral semi-solid intake at baseline; able to maintain oral intake over the trial.

You may not qualify if:

• Fed by nasogastric tube, gastrostomy, or total parenteral nutrition
• Cancer of the brain, Cancer of the regions which impact an individual's ability to consume food.
• A known hypersensitivity / allergy to eggs.
• Enrolment in any other clinical protocol or investigational study that may interfere with study procedures.
• Poorly controlled chronic illnesses or other inflammatory diseases (e.g. Chronic Obstructive Pulmonary Disease(COPD), uncontrolled non-insulin dependent diabetes, rheumatoid arthritis).
• In a clinician opinion, patients who have medical conditions that could interfere with nutrient metabolism or absorption (e.g., short bowel syndrome, Crohn's disease, etc.)

Sponsors & Collaborators

• University of Alberta: lead
• Egg Farmers of Canada: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2C8, Canada

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Vera Mazurak, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of the two parallel arms (i.e., egg intervention arm and no intervention arm) for the first 4 weeks. Starting from week 5, the participants in the egg intervention arm will continue with the intervention till week 8 and the participants in the control arm will crossover to the intervention arm for weeks 5 to 8.

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 15, 2023
• Study Start: September 1, 2023
• Primary Completion: June 15, 2025
• Study Completion: June 15, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)